RAPS Quebec Local Networking Group

🔎 Having difficulty following up on all MDCG guidance documents that have been recently issued by the European Commission? In this episode, Tibor Zechmeister gives a straight to the point overview of the key categories of the recent MDCG documents and explains their significance to the manufacturers. Tibor Zechmeister has worked in medical device regulatory affairs for more than 12 years. He has established and co-founded businesses addressing neurodegenerative illnesses, serving in capacities as head of regulatory, PRRC, and thus witnessing the challenges of medical device manufacturers within the European regulatory framework. Tibor currently oversees Regulatory and Quality at Flinn.ai, where he ensures compliance and quality for state-of-the-art automation and AI tools for regulatory compliance. Additionally to this, he works as an External Auditor at Notified Body 1304. This video covers the following topics: ⌛ 8:45s - Why it is important to comply with the current versions of MDCG ⌛ 7:35s - An overview of MDCG 2024-11 on Qualification of IVDDs ⌛ 6:07s - An update of MDCG 2020-16 on Classification of IVDDs ⌛ 5:00s - "Nice to read / know" category of MDCG documents ⌛ 3:20s - Advice to regulatory / quality professionals on ensuring compliance to MDCG documents ( ✔️ Bonus: how to avoid getting into a trouble with a NB auditor 😊 ) Regulatory Affairs Professionals Society (RAPS) #regulatoryaffairs #medicaldevices #mdr #compliance

📢 📢 📢 RAPS Quebec Local Networking Group is excited to announce an upcoming in-person networking opportunity for women leaders in Drug Safety, Medical Information, Quality, and Regulatory Affairs initiated by ZENITH PV happening at the end of November in Montreal. 📌 What: The main goal is to build your network with fellow colleagues while discussing hot topics in the pharmaceutical industry in a relaxing setting. ❔ How to participate: Please send a private message to RAPS Quebec LNG for additional details. 📍 📅 ⏰Event Details: End of November with exact information to be confirmed via poll - please reach out to RAPS Quebec LNG through private message to express your interest in attending. ✅ Cost: FREE! There is no cost to attend this event and it is up to you what refreshments to purchase individually. We look forward to seeing you there! #RAPS #DrugSafety #MedicalInformation #Quality #RegulatoryAffairs #WomenLeaders #Networking

📣 What is new in the field of medical devices biocompatibility assessment? In this discussion, Marina Daineko shares a brief overview of the most recent regulatory developments on this subject in the EU and US. Marina Daineko is a seasoned Biocompatibility Consultant based in Poland, specializing in ISO 10993-1. With extensive experience in the medical device industry, she adeptly develops biocompatibility assessment aligned with ISO 14971:2019, EU Medical Device Regulation as well as FDA Guidance. Her expertise extends to ensuring compliance with regulatory requirements across various global markets. Marina works as a consultant at Intrinsic Medical Group, LLC. that offers a diverse spectrum of Biological Safety services to fit the needs of a wide range of medical device manufacturers. Their strategies are proven to meet the requirements of modern day foreign body and domestic regulations. This video covers the following topics: ✅ ⌛ (5:55 minutes remaining): Updates to ISO 10993 standard series in EU ✅ ⌛ (4:08 minutes remaining): FDA ASCA Program, FDA Guidance on Chemical Analysis and Recommendations ✅ ⌛ (2:35 minutes remaining): Advice to regulatory professionals in light of the upcoming changes Regulatory Affairs Professionals Society (RAPS) #medicaldevices #regulatoryaffairs #biocompatibility

🌐 RAPS Quebec Local Networking Group est ravi de présenter notre événement en personne à Montréal sur les soumissions à la FDA pour les instruments médicaux 🌐   Ne manquez pas l'opportunité de participer à notre prochain événement en personne avec le conférencier Eric Franca directeur adjoint du FDA CDRH, Division of Standards Conformity Assessment.   Par une webdiffusion en direct, Eric discutera des normes reconnues par la FDA pour les instruments médicaux, notamment eSTAR et ASCA (Accreditation Scheme for Conformity Assessment). Il expliquera comment citer ces normes pour maximiser leur efficacité en tant qu'outils permettant de soutenir et de rationaliser les soumissions des instruments médicaux.   Après la présentation informative d’Eric, une séance de réseautage en personne aura lieu au cours de laquelle des canapés, des boissons gazeuses, ainsi que du café et du thé seront disponibles pour favoriser des discussions fructueuses.    Détails de l'événement clé: 🚀 Title: FDA Road Show-Upping Your Conformity Assessment Game: Putting Standards to Work to Streamline Device Review 📅 Date: mercredi, October 23rd, 2024 ⏰ Heure: 17:30 - 21:00 HAE 📍 Lieu: Le Crystal Reception Hall, 5285 Henri Bourassa Blvd O. ✅ Inscription – Membres: $55 CAD / Non-Membres: $68 CAD 🚗 Stationnement: Gratuit!   Inscrivez-vous maintenant pour garantir votre place et obtenir des informations précieuses de notre conférencier expérimenté et développer votre réseau.   Cliquez ici pour vous inscrire: https://lnkd.in/dRZK7v2R   Ne manquez pas cette opportunité d'apprentissage exceptionnelle car les places sont limitées. Au plaisir de vous voir à l'événement!   Veuillez noter que la présentation sera en anglais, tandis que la séance de réseautage sera bilingue (français et anglais).   #RAPSQuebecLNG #RAPS #InstrumentsMédicaux #FDA #AffairesRéglementaires

📣 Planning an FDA medical device submission and would like to know how to streamline and speed up the process? The FDA Accreditation Scheme for Conformity Assessment program (ASCA) is designed exactly for that! Our expert, SUMATHA KONDABOLU, shares a general overview of the program and its advantages. 🔔 If you would like to learn in detail about the practical applications of this program directly from the FDA CDRH Assistant Director, Eric Franca, join RAPS Quebec Local Networking Group in-person event in Montreal on October 23, 2024. Event registration link https://lnkd.in/dRZK7v2R SUMATHA KONDABOLU is a Senior Quality Specialist and advisor at Qualio, where she assists organizations—from startups to industry leaders—in navigating quality management systems. Her expertise covers key regulatory frameworks such as FDA QSR, Canada’s medical device regulations, MDSAP, and the EU’s MDR/ IVDR. Sumatha's innovative approach to quality assurance has significantly advanced the industry, and her auditing experience with ISO standards like ISO 13485, ISO 17025, ISO 27001, ISO 27701, ISO 42001, and ISO 9001 reflects her dedication to high quality standards. With a bachelor’s degree in pharmacy and a master’s degree in chemistry, her robust educational background enhances her practical experience in complex regulatory environments. Regulatory Affairs Professionals Society (RAPS) #medicaldevices #regulatory #FDA

🔔 Upcoming Event Alert! 🔔 RAPS Quebec Local Networking Group has an exciting In-Person event coming up! 🎯 Click the link below for more information🔗👇 https://lnkd.in/gg4g5DPr #RAPS #RegulatoryAffairs #Networking #QuebecEvents #ProfessionalGrowth

📣 The FDA rule over LDTs (Laboratory Developed Tests) and ACLA lawsuit is an on-going evolving story. However, what is at the core of this debate and why did the FDA introduce this final rule? In this discussion, Tiea Theurer explains the important aspects of the LDT rule from her practical experience as a consultant. Tiea has a BS in Medical Technology (IVD). She worked 10+ years in a hospital laboratory including LDTs. She has worked for IVD manufacturers who market IVD and RUO products. Tiea completes 3rd party audits for IVD and medical devices, supports private clients who are developing IVD and RUO products, and provides Quality System training. Tiea is partnered with Quarem Consulting helping laboratories adjust to the FDA final rule for LDTs. This video covers the following subjects: ✅ ⌛ 00:03 (8:45 minutes remaining): Why did the FDA include complaint handling and MDR reporting in the final LDT rule? ✅ ⌛ 02:09 (6:43 minutes remaining): What actions should be taken by the LDT manufacturers? ✅ ⌛ 03:04 (5:30 minutes remaining): The importance of detailed investigations into complaints and adverse events; design and purchasing controls, CAPA ✅ ⏳ 06:59 (2:07 minutes remaining): FDA additional guidance documents on the implementation of the LDT final rule Regulatory Affairs Professionals Society (RAPS) RAPS Quebec Local Networking Group

Pour la première fois en Amérique du Nord, la 23e Réunion Annuelle de la Société Internationale de Pharmacovigilance (ISoP) se tiendra à Montréal ! RAPS Quebec Local Networking Group a collaboré avec ISoP Events pour vous offrir une remise exclusive de 20 % sur les frais d'inscription à cet événement prestigieux ! Les étudiants peuvent bénéficier d'une remise de 35 % ! ✅ Contactez l'administrateur de RAPS Quebec Local Networking Group sur LinkedIn pour obtenir votre code promo pour l'inscription. 🗓 Du 1er au 5 octobre 2024 📍 Centre Mont-Royal, 2200 rue Mansfield, Montréal ✒ Lien d'inscription : www.isop2024montreal.org Du 1er au 5 octobre, au Centre Mont-Royal (2200, rue Mansfield– Montréal), cet événement international de premier plan réunira des leaders mondiaux issus de divers horizons : gouvernements et agences réglementaires (FDA, Santé Canada, Agence européenne des médicaments, Medicines and Healthcare Products Regulatory Agency, Swissmedic, ANSM, et Saudi FDA), l’industrie pharmaceutique et biotechnologique (Pfizer, Novartis, Baye Bristol Myers Squibb, Alexion Pharmaceuticals, Boehringer Ingelheim et CSL), ainsi que des CRO, sous-traitants, académiques et chercheurs de grandes institutions telles que l’Université McGill, l’Université de Montréal, l’Université Laval, l’Université de la Colombie-Britannique, l’Université Rutgers, l’Université Harvard, l’Université de Bordeaux, la Faculté des Sciences Humaines et Sociales - Sorbonne (Université Paris Descartes), l’Université de Cambridge, l’Université Duke, le Massachusetts College of Pharmacy and Health Sciences, l’Université de Boston et l’Université Stanford.   Cette conférence unique représente une occasion exceptionnelle pour les étudiants, professionnels et organisations du Québec et du Canada de collaborer avec leurs homologues internationaux tout en mettant en valeur l’expertise locale dans le domaine de la pharmacovigilance et de la sécurité des médicaments. #pharmacovigilance #drugsafety

📣 Under Vanessa’s Law, Health Canada requires all hospitals to report serious ADRs (adverse drug reactions) within 30 days. However, what is the real situation of the hospitals reporting compliance rate and why is this subject relevant to regulatory professionals working with the pharmaceutical companies? In this video, Manar Hammood, Founder & Director of PV Operations at ZENITH PV, explains the regulatory importance of the mandatory hospital ADR reporting and provides an actionable advice to pharmacovigilance/regulatory professionals. ZENITH PV is a Canadian pharmacovigilance and Medical Information services firm helping pharmaceutical and medical device companies attain and maintain compliance with drug safety standards in Canada and globally. Manar firmly believes that PV can play a major role in helping physicians and hospitals use drugs and devices safely and improve patient outcomes. Her work is recognized widely in the industry. She is an active member of industry working groups and is committed to creating and managing impactful change. This video covers the following topics: ✅ ⏳00:10 (07:43 remaining) – History of Vanessa’s Law and the current state of the hospitals ADR reporting compliance rate ✅ ⏳ 02:24 (05:30 remaining) – Reasons for low hospitals ADR reporting rates ✅ ⏳04:22 (03:32 remaining) – Innovative ways to increase hospitals’ adherence to the ADR reporting requirements ✅ ⏳05:53 (02:02 remaining) – Practical advice to PV / regulatory professionals working with the pharmaceutical companies on adjusting to the expected increase in ADR reports from hospitals For more details on this topic, attend the upcoming webinar on Sep 24th, 2024 covering “Mandatory reporting of Serious ADRs by hospitals - Introduction to HC Requirements” (registration link https://lnkd.in/gPsFFaqf) Regulatory Affairs Professionals Society (RAPS) #pharmacovigilance #regulatoryaffairs #RAPS

✨ What an incredible time at the RAPS Chapter/ LNG Meet & Greet! ✨ A big thank you to everyone who joined us at the 'RAPS Quebec LNG Meet & Greet' for an inspiring and insightful event! It was fantastic to connect with regulatory professionals, exchange ideas, and build stronger relationships within our Quebec regulatory community. 🌟 The energy and passion shared by all attendees truly highlight the value of these opportunities for collaboration and networking. 💡 We look forward to continuing these discussions and growing together as we face the exciting challenges and opportunities in the regulatory world. Stay tuned for more events and opportunities to connect! Let’s keep this momentum going. RAPS Quebec Local Networking Group RAPS Ontario Chapter RAPS Western Canada Chapter